Search Results

The OBERON, laser surgery fiber, Side Fire laser surgery fibers are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm- 2100mm) OBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, 1.44YAG and Diode Lasers (532mm - 2100mm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

OBERON's laser surgery fiber contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be also used with hand pieces.

The document provided is a 510(k) summary for the OBERON Laser Surgery Fiber, indicating that it has been found substantially equivalent to predicate devices. This type of submission focuses on demonstrating equivalence rather than proving device performance against specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain a table of acceptance criteria and reported device performance as it relates to clinical efficacy or accuracy metrics. Instead, it asserts substantial equivalence based on technical characteristics and intended use.

Here's an analysis of the information that can be extracted or deduced from the provided text, and what is explicitly not present:

1. A table of acceptance criteria and the reported device performance:

• Not explicitly available in the provided document. The document states, "The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included." This implies reliance on the performance of the predicate devices.
• The table in section {4} ("Predicate Devices - 1 - Per 21 CFR 807.92 item (6) Summary with comparison values") provides a comparison of technical characteristics and intended use between the OBERON device and several predicate devices (MED-Fibers, Inc. K124003 and Fiberoptic Fab K120810). It does not present quantitative performance data against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable/Not provided. Since no specific performance testing against acceptance criteria is included in this 510(k) summary, there is no mention of a test set, its sample size, or data provenance. The submission relies on the "well established and documented" performance of the technology in general and the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not provided. As no specific performance testing is documented, there is no mention of experts or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. No test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, not done. This device is a laser surgery fiber, a physical medical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not provided. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable/Not provided. No specific performance study with ground truth is described.

8. The sample size for the training set:

• Not applicable/Not provided. This is a physical device, and machine learning training sets are not relevant.

9. How the ground truth for the training set was established:

• Not applicable/Not provided.

Summary of what is available from the document regarding acceptance and studies:

The document is a 510(k) Pre-market Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically involves comparing the new device's technological characteristics, intended use, and safety/effectiveness data (or lack thereof, if equivalence is strong) to the predicate.

• Acceptance Criteria (Implied by 510(k) process): The ultimate acceptance criterion for a 510(k) submission is that the device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
• Study Proving Acceptance: The "study" is the 510(k) submission itself, which presents a comparative analysis. The document states:
  • "The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included."
  • "The OBERON's laser surgery fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices."
  • "The OBERON's laser surgery fibers are as safe and effective for the indications for use as the Laser Peripherals, Leoni, Lumenis, MED-Fibers, Cynosure, Fiberoptic Fabrications and CermaOptec fiber optic laser delivery systems previously cleared thus the OBERON's laser surgery fibers are substantially equivalent."

This means the "proof" is the argument of equivalence based on the shared fundamental technology and intended use with multiple predicate devices, rather than a novel study designed to meet specific performance targets for a new technology or application.

Ask a specific question about this device